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Preventive substrate ablation in chronic post-myocardial infarction patients with high-risk scar characteristics for ventricular arrhythmias: rationale and design of PREVENT-VT study

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Abstract

Background

Recent studies showed that an early strategy for ventricular tachycardia (VT) ablation resulted in reduction of VT episodes or mortality. Cardiac magnetic resonance (CMR)-derived border zone channel (BZC) mass has proved to be a strong non-invasive predictor of VT in post-myocardial infarction (MI). CMR-guided VT substrate ablation proved to be safe and effective for reducing sudden cardiac death (SCD) and VA occurrence.

Methods

PREVENT-VT is a prospective, randomized, multicenter, and controlled trial designed to evaluate the safety and efficacy of prophylactic CMR-guided VT substrate ablation in chronic post-MI patients with CMR-derived arrhythmogenic scar characteristics. Chronic post-MI patients with late gadolinium enhancement (LGE) CMR will be evaluated. CMR images will be post-processed and the BZC mass measured: patients with a BZC mass > 5.15 g will be eligible. Consecutive patients will be enrolled at 3 centers and randomized on a 1:1 basis to undergo a VT substrate ablation (ABLATE arm) or optimal medical treatment (OMT arm). Primary prevention ICD will be implanted following guideline recommendations, while non-ICD candidates will be implanted with an implantable cardiac monitor (ICM). The primary endpoint is a composite outcome of sudden cardiac death (SCD) or sustained monomorphic VT, either treated by an ICD or documented with ICM. Secondary endpoints are procedural safety and efficiency outcomes of CMR-guided ablation.

Discussion

In some patients, the first VA episode causes SCD or severe neurological damage. The aim of the PREVENT-VT is to evaluate whether primary preventive substrate ablation may be a safe and effective prophylactic therapy for reducing SCD and VA occurrence in patients with previous MI and high-risk scar characteristics based on CMR.

Trial registration

ClinicalTrials.gov, NCT04675073, registered on January 1, 2021.

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Data availability

Not applicable. Enrollment is currently ongoing, and no datasets were generated for analysis yet.

Abbreviations

BZC:

Border zone channel

CL:

Cycle length

EGM:

Electrogram

EPS:

Electrophysiological study

FAM:

Fast anatomical map

ICM:

Implantable Cardiac Monitoring

IHD:

Ischemic heart disease

ICD:

Implantable cardioverter defibrillator

LGE-CMR:

Late gadolinium enhancement-cardiac magnetic resonance

LVEF:

Left ventricular ejection fraction

MDCT:

Multi-detector computed tomography

MI:

Myocardial infarction

PSI:

Pixel signal intensity

PVS:

Programmed ventricular stimulation

SMVT:

Sustained monomorphic ventricular tachycardia

TOE:

Transoesophageal echocardiogram

TTE:

Transthoracic echocardiogram

VA:

Ventricular arrhythmia

VT:

Ventricular tachycardia

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Funding

The study was partially funded by Biotronik, Germany.

Author information

Authors and Affiliations

  1. Teknon Medical Centre, Heart Institute, Calle Villana 12 (08022), Barcelona, Spain

    Giulio Falasconi, Diego Penela, David Soto-Iglesias, Pietro Francia, Cheryl Teres, Daniel Viveros, Aldo Bellido, Jose Alderete, Julia Meca-Santamaria, Paula Franco, Marta Díaz-Escofet, Claudia Scherer, Marina Huguet, José-Tomás Ortiz-Pérez, Julio Martí-Almor & Antonio Berruezo

  2. Cardiology, Department of Clinical and Molecular Medicine, St. Andrea Hospital, Sapienza University, Rome, Italy

    Pietro Francia

  3. El Pilar Hospital, Barcelona, Spain

    Augusto Ordoñez

  4. Catalunya General University Hospital, Barcelona, Spain

    Maria Matiello & Giuliana Maldonado

  5. Pompeu Fabra University, Barcelona, Spain

    Óscar Cámara

  6. Campus Clínic, University of Barcelona, Barcelona, Spain

    Giulio Falasconi, Daniel Viveros, Jose Alderete & José-Tomás Ortiz-Pérez

Authors
  1. Giulio Falasconi
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Contributions

GF: study concept and design, manuscript drafting, and critical revision. DP: study concept and design, manuscript drafting, and critical revision. DSI: study concept and design, manuscript drafting, and critical revision. AB: study concept and design, manuscript drafting, and critical revision. All authors have read and approved the manuscript.

Corresponding author

Correspondence to Antonio Berruezo.

Ethics declarations

Ethics Approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the local Ethics Committee.

Conflict of interest

A. Berruezo is a stockholder of Galgo Medical. D. Soto-Iglesias is an employee of Biosense Webster. A. Berruezo received speaker fees from Biosense and research grants from Biotronik. P. Francia received speaker fees, research, and educational grants from Boston Scientific and Abbott. The other authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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Giulio Falasconi M.D. and Diego Penela M.D., Ph.D. equally contributed to the article and should be considered as shared first authors.

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Falasconi, G., Penela, D., Soto-Iglesias, D. et al. Preventive substrate ablation in chronic post-myocardial infarction patients with high-risk scar characteristics for ventricular arrhythmias: rationale and design of PREVENT-VT study. J Interv Card Electrophysiol 66, 39–47 (2023). https://doi.org/10.1007/s10840-022-01392-w

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